Table 2.
Adverse events (n = 71) during a median follow up of 36 months of TG therapy
| Grade 1 (mild) (n = 59) |
Grade 2 (moderate) (n = 9) |
Grade 3 (severe) (n = 3) |
||||
|---|---|---|---|---|---|---|
| General, neurological and psychological | Flu-like symptoms | 7 | – | – | ||
| Blood, lymphatic and vascular disorders | Bone marrow suppression | 12 | Bone-marrow suppression | 2 | – | |
| Musculoskeletal and skin disorders | Alopecia | 5 | – | – | ||
| Rash | 9 | |||||
| Arthralgia/myalgia | 8 | |||||
| Hepatobiliary disorders | DILI | 9 | DILI | 3 | Portal hypertension | 2 |
| Gastrointestinal disorders | Nausea | 5 | Diarrhea | 1 | Pancreatitis | 1 |
| Abdominal pain | 4 | |||||
| Infections and infestations | – | EBV infection | 1 | Herpetic eye infection | 1 | |
| Neoplasm benign and malign | – | Melanoma | 1 | Diffuse large B-cell lymphoma | 1 | |
| Recurrent breast cancer | 1 | |||||
DILI Drug-induced liver injury, DILI grade 1 is defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 1.25 and ≤ 3 upper limit of normal (ULN) and total bilirubin > 1.25 and ≤ 2 ULN, grade 2 is defined as ALT and AST > 3 and ≤ 5 ULN and total bilirubin > 2 and ≤ 3 ULN. Bone marrow suppression: grade 1 < =25% reduction from normal cellularity for age, grade 2: > 25 - < 50% reduction from normal cellularity for age, grade 3: > 50 - < =75% reduction cellularity from normal for age